US Patent 5,593,427
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`DECLARATION OF WAYNE C. McDANIEL, Ph.D.
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`I.
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`BACKGROUND AND QUALIFICATIONS
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`(1) My name is Wayne Charles McDaniel. I am currently Associate Director of
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`the Technology Management and Industry Relations office at the University of Missouri-
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`Columbia. I am also an Adjunct Professor of Electrical and Computer Engineering at the
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`University of Missouri. During my career, I have worked extensively in biomedical
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`engineering research involving cardiac therapy and defibrillation. I am expert in the areas of
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`internal atrial and ventricular defibrillation, external ventricular defibrillation, experimental
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`methods for defibrillation research, and cardiac safety of stun guns.
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`(2)
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`I hold a Bachelor of Arts in Biology, a Master of Science in Electrical
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`Engineering with a biomedical engineering emphasis, and a Doctorate of Philosophy in
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`Electrical Engineering with a biomedical engineering emphasis from the University of
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`Missouri-Columbia.
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`(3)
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`From 2001 to 2011, I held the position of Senior Licensing and Business
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`Development Associate of the Technology Management and Industry Relations office at the
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`University of Missouri-Columbia. From 1987 to 2001, I was a Research Assistant Professor
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`of Cardiothoracic Surgery at the University of Missouri-Columbia. From 1993 to 2001, I was
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`LIFECOR427-1004
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`DECLARATION OF WAYNE C. McDANIEL, Ph.D.
`
`I.
`
`BACKGROUND AND QUALIFICATIONS
`
`(1) My name is Wayne Charles McDaniel. I am currently Associate Director of
`
`the Technology Management and Industry Relations office at the University of Missouri-
`
`Columbia. I am also an Adjunct Professor of Electrical and Computer Engineering at the
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`University of Missouri. During my career, I have worked extensively in biomedical
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`engineering research involving cardiac therapy and defibrillation. I am expert in the areas of
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`internal atrial and ventricular defibrillation, external ventricular defibrillation, experimental
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`methods for defibrillation research, and cardiac safety of stun guns.
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`(2)
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`I hold a Bachelor of Arts in Biology, a Master of Science in Electrical
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`Engineering with a biomedical engineering emphasis, and a Doctorate of Philosophy in
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`Electrical Engineering with a biomedical engineering emphasis from the University of
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`Missouri-Columbia.
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`(3)
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`From 2001 to 2011, I held the position of Senior Licensing and Business
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`Development Associate of the Technology Management and Industry Relations office at the
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`University of Missouri-Columbia. From 1987 to 2001, I was a Research Assistant Professor
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`of Cardiothoracic Surgery at the University of Missouri-Columbia. From 1993 to 2001, I was
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`LIFECOR427-1004
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`US Patent 5,593,427
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`Acting Director of Cardiothoracic Surgery Laboratory Investigation at the University of
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`Missouri.
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`(4)
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`I have over 35 years of experience in the biomedical engineering field and
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`have published extensively in electrical ventricular defibrillation. For over twenty-five years,
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`I have conducted and received numerous grants for research relating to cardiac therapy and
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`defibrillation.
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`(5)
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`I was one of the pioneers of the biphasic waveform that is now used in
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`virtually all automatic implantable cardioverter defibrillators and virtually all transthoracic
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`defibrillators, including automatic external defibrillators.
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`(6)
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`I have authored or co-authored 34 published articles relating to cardiac
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`therapy and defibrillation, including articles titled “Transthoracic Defibrillation of Dogs with
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`Edmark, Biphasic, and Quadriphasic waveforms,” “Double-pulse transthoracic defibrillation
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`in the calf using percent fibrillatory cycle length as spacing determinate,” and “Relationship
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`between efficacy and frequency domain characteristics of defibrillatory shocks.”
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`(7)
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`I have given 46 presentations at national or international meetings, including
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`a presentation entitled “Multiphasic truncated exponential waveforms require less peak
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`current for atrial defibrillation than optimal biphasic waveforms” to the 22nd Annual Scientific
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`Sessions of the North American Society for Pacing and Electrophysiology, in Boston,
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`Massachusetts in May of 2001 and a presentation entitled “Comparison of the Efficacy of
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`Two Transthoracic Biphasic Waveform Defibrillators” to the Europace 2003 Congress in
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`US Patent 5,593,427
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`Dec. 2003 in Paris, France. I have presented at 33 colloquiums and symposiums, including
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`presentations on ventricular and atrial defibrillation.
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`(8)
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`I am the sole inventor on U.S. Patent No. 6,738,664 entitled “Method of and
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`apparatus for atrial and ventricular defibrillation or cardioversion with an electrical waveform
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`optimized in the frequency domain,” which issued on May 18, 2004.
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`(9)
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`A copy of my C.V. is attached as Appendix A.
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`II.
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`STATUS AS AN INDEPENDENT EXPERT WITNESS
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`(10)
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`I have been retained in this matter by Fish & Richardson P.C. to provide
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`various opinions regarding U.S. Patent No. 5,735,879 (“the ‘879 patent); U.S. Patent No.
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`5,749,905 (“the ‘905 patent”); U.S. Patent No. 6,047,212 (“the ‘212 patent); U.S. Patent No.
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`5,607,454 (“the ‘454 patent); U.S. Patent No. 5,836,978 (“the ‘978 patent”); U.S. Patent No.
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`5,749,904 (“the ‘904 patent”); U.S. Patent No. 5,593,427 (“the ‘427 patent”); and U.S. Patent
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`No. 5,803,927 (“the ‘927 patent”) (collectively, “the Philips Waveform Patents”). I am being
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`compensated at the rate of $300 per hour for my work. My fee is not contingent on the
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`outcome of this matter or on any of the opinions I provide below.
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`(11)
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`I have been advised that Fish & Richardson represents ZOLL Lifecor Corp. in
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`this matter. I have no financial interest in ZOLL Lifecor Corp.
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`(12)
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`I have been advised that Philips Electronics North America Corp. (“Philips” or
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`“Patent Owner”) owns the Philips Waveform Patents. I have no financial interest in Philips
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`Electronics North America Corp. or in the Philips Waveform Patents.
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`US Patent 5,593,427
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`III.
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`MATERIALS CONSIDERED
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`(13)
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`In arriving at the opinions set forth herein, I have reviewed the Philips
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`Waveform Patents and relevant portions of their respective file histories.
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`(14) Additional materials that I have reviewed and relied upon in arriving at the
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`opinions set forth herein are: (1) Bell (Appendix B); (2) Pless (Appendix C); (3) Kroll
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`(Appendix D); (4) Schuder (Appendix E); (5) Swanson (Appendix F); (6) De Coriolis
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`(Appendix G); (7) Ideker (Appendix H); (8) Fain (Appendix I); (9) Baker (Appendix J); (10)
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`Packer (Appendix K); (11) Hahn (Appendix L); (12) Bach (Appendix M); (13) Adams
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`(Appendix N); (14) Herleikson (Appendix O); and (15) Cameron (Appendix P).
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`IV.
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`DESCRIPTION OF THE RELEVANT FIELD AND RELEVANT TIMEFRAME
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`(15) Based on my review of the Philips Waveform Patents and the materials listed
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`in Appendices B-P, I conclude that the relevant field of the Philips Waveform Patents for
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`purposes of my testimony is waveforms used for defibrillation, and apparatus and
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`techniques for generating and delivering such waveforms. I have been advised that the
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`relevant timeframe is August 1993, which is the date that the applications that lead to the
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`Philips Waveform Patents were filed.
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`(16) As described in Section I above, I have extensive experience in the field of
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`defibrillation waveforms, and apparatus and techniques for generating and delivering such
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`waveforms.
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
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`(17)
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`I have been advised that “a person of ordinary skill in the relevant field” is a
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`mythical person to whom an expert in the relevant field could assign a routine task with
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`reasonable confidence that the task would be successfully carried out. Here, the relevant
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`field is waveforms used for defibrillation, and apparatus and techniques for generating and
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`delivering such waveforms. Because these devices are used to deliver a shock to a
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`patient’s heart, people engaged in developing these devices and related methods need to
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`have a high level of skill. Based upon my experience in this area, one of ordinary skill in the
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`art in this field at the relevant time frame would have had an advanced (post-Bachelor’s)
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`degree in electrical engineering, biomedical engineering, or some closely related field, with
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`at least 5 years of work experience in one or more of these fields, and at least 5 years of
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`experience in developing (e.g., designing or implementing) medical devices for defibrillation,
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`pacing, and/or cardiac medical devices (which experience could have overlapped in whole
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`or part with the at least 5 years of experience in the fields of electrical engineering or
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`biomedical engineering), or the equivalent of such experience. The person of ordinary skill
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`in the art also must have been intimately familiar with the design of, theory behind,
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`principles of operation of, and intended use of defibrillators, as well as the principles of
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`human physiology that underlie the indications of use for defibrillators (cardiac arrest and
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`ventricular fibrillation), and the theories as to why the delivery of certain shocks may be
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`useful to correct these conditions.
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`(18) Based on my experiences, I have a good understanding of the capabilities of
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`a person of ordinary skill in the relevant field. Indeed, in addition to being a person of at
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`least ordinary skill in the art, I have worked closely with many such persons over the course
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`of my career, and I have regularly taught material fundamental to the art in my role as
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`professor and researcher over the past 35 years.
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`VI.
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`BACKGROUND OF THE RELEVANT TECHNOLOGY
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`(19) Sudden cardiac death is the most common mode of death in our adult
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`population, accounting for an estimated 30 percent of all natural deaths. Sudden cardiac
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`arrest occurs when the heart stops beating in an organized way and instead begins
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`fibrillating in a random manner. Many of the hearts of sudden cardiac death victims appear
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`essentially normal at the time of autopsy, causing some investigators to refer to them as
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`hearts that were “too good to die.” One major cause of sudden cardiac death is a
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`phenomenon called ventricular fibrillation (VF) which occurs in structurally good hearts over
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`900 times a day in the U.S. alone in out-of-hospital patients. In VF, the individual muscle
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`fibers of the heart no longer contract in unison, but rather there are waves of contraction
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`that run randomly through the heart. A direct consequence of VF is the inability of the heart
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`to pump blood, which means the patient will suffer irreversible brain damage and then death
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`if not treated promptly.
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`(20) Electrical defibrillation is a treatment of choice for ventricular fibrillation and
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`consists of delivering a therapeutic dose of electrical energy to the patient’s heart, which
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`US Patent 5,593,427
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`depolarizes a critical mass of the heart muscle. This depolarization terminates the
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`dysrhythmia, allowing the patient’s normal sinus rhythm to be reestablished. Defibrillators,
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`which were first developed in the mid-1900s, are devices that restore normal contractions in
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`the heart muscle by delivering a powerful shock via electrodes attached to the patient. The
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`goal of a defibrillation shock is to deliver the appropriate amount of current to the patient to
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`reestablish normal sinus rhythm, while minimizing damage to the patient’s heart. The shock
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`is generally delivered by charging an energy source, such as a capacitor over time, and
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`then closing a switch to release the charge. A shock takes just a fraction of a second.
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`(21) The flow of electrical current released during the shock has a shape that can
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`be characterized by a time versus voltage graph that shows the “waveform” of the shock.
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`For example, if a shock is delivered freely, the “waveform” is simply an exponentially
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`decaying shape that approaches zero after a relatively long period of time. For successful
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`defibrillation, the amount of current delivered to the heart varies between patients on
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`account of a given patient’s body mass, temperature and diaphoresis—collectively referred
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`to as patient impedance. To account for patient impedance, the waveform of the shock can
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`be modified, or shaped, by altering the initial and/or terminal voltage used in delivering the
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`shock, as well as the duration of the shock. Such shaping allows one to modify the amount
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`of current released into the patient.
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`(22) Modern defibrillators can either be external units, where electrodes are placed
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`on the patient’s torso to deliver a shock to the patient’s heart, or internal devices, in which
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`case a small electrical impulse generator is implanted into the body of a patient at risk of
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`cardiac arrhythmia. The implantable device monitors the patient’s cardiac rhythms and
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`automatically delivers a therapeutic shock if dysrhythmia is detected. Because external
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`defibrillators indirectly deliver therapeutic shocks to the heart (i.e., through layers of fat,
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`tissue, and skin), it is important to be able to modify different aspects of the waveform for
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`patients of different sizes and body types.
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`Brief History of Defibrillators
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`(23) The earliest recorded defibrillation in humans with internal electrodes was
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`accomplished in 1947. The first electrical waveform used for defibrillation was 60 Hz
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`alternating current (AC), which is also used as standard household current. Similarly, the
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`first recorded defibrillation of a human with external electrodes was accomplished in 1956,
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`also by an AC waveform defibrillator.
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`(24) AC waveform defibrillators were replaced in the 1960s by the development of
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`the Lown and Edmark waveform defibrillators. These defibrillators comprised a resistor (R),
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`an inductor (L), and a capacitor (C), and were therefore referred to as RLC defibrillators.
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`RLC defibrillators were considered to be an advancement over AC defibrillators in that they
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`were portable and did not need to be tethered to a power line. Both the Lown and Edmark
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`waveforms delivered predominantly monophasic waveforms. However, under certain
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`patient resistances, one or more negative phases would be observed. Therefore, both
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`Edmark and Lown waveform defibrillators would generate multiphasic waveforms under the
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`right circumstances.
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`(25)
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`In 1966, John Schuder et al. published a study of the transthoracic
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`defibrillation efficacy of triangular and trapezoidal waveforms in dogs. This study followed a
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`similar study of monophasic square waveforms. This study found that a long slow decay on
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`a waveform would reduce the efficacy, whereas truncating the descending triangular
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`waveform yielded a superior waveform. This study laid the foundation for capacitor
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`discharge defibrillators not containing an inductor.
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`(26)
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`In 1971, Schuder et al. extended this work to true capacitive discharge
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`waveforms (as opposed to triangular waveforms above) and found that truncation of long-
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`duration waveforms significantly improved defibrillation success. The Schuder lab
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`pioneered this monophasic truncated exponential (MTE) waveform (which is sometimes
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`called the Schuder waveform) for defibrillation. One advantage to the MTE waveform was
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`the reduction of the peak current, which was believed to cause cardiac damage with the
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`Edmark and Lown waveforms. Another advantage to the MTE waveform (when
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`implemented in clinical devices) was that one could compensate for differing thoracic
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`impedance values seen with different patients by delivering a constant value of delivered
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`energy across a wide range of patient impedances. This was done by monitoring a patient-
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`related electrical parameter and terminating the shock based on that measured value.
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`(27) Around the same time, the Schuder lab published a research study of the first
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`implantable defibrillator and incorporated the MTE waveform in that defibrillator. The MTE
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`waveform was particularly well suited for the implantable defibrillator, in that it could be
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`generated without the use of an inductor, which would be too large and heavy for use in an
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`implantable device.
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`(28)
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`In the early 1980s, John Schuder, in collaboration with Janice Jones,
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`theorized that a biphasic waveform would cause less post-shock dysfunction than the MTE
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`waveform for defibrillation. Biphasic waveforms differ from monophasic waveforms in that
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`the shock delivered to the patient’s heart in a monophasic shock is delivered in one
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`direction only from one electrode to the other. In biphasic waveform defibrillation, the shock
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`passes in one direction from one electrode to the next and then reverses direction, traveling
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`back to the original electrode. That is, in a biphasic waveform the pulse alternates between
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`positive and negative polarities.
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`(29) The Schuder lab began a series of studies of the biphasic waveform with the
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`first study involving what are now called biphasic truncated exponential (BTE) waveforms.
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`The first study involving implantable electrodes was promising (published in 1981), so the
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`Schuder lab modified its high power research defibrillator to enable it to generate biphasic
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`waveforms for external defibrillation of human-sized animals (device made public in 1982).
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`The first study with the modified research defibrillator involved symmetric rectangular
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`biphasic waveforms (equal constant currents and equal phase durations), which was
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`US Patent 5,593,427
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`published in 1983. Then a study of asymmetric rectangular biphasic waveforms (unequal
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`constant currents and equal phase durations) was published in 1984.
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`(30) The studies of Schuder and Jones attracted the attention of both an
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`implantable defibrillator manufacturer (Cardiac Pacemaker Inc.) and an external defibrillator
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`manufacturer (Physio Control). Cardiac Pacemakers Inc. (CPI) and Physio Control worked
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`collaboratively with the Schuder lab, the Jones lab, and other labs such as Ray Ideker’s lab.
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`About once per year during this time period, representatives of each of the labs and each of
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`the companies met for a research conference. It was known to all researchers involved at
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`the time that the biphasic waveforms showed promise to dramatically improve both the
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`implantable defibrillators made by CPI and the transthoracic defibrillators made by Physio
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`Control.
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`(31)
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`In 1984 the Schuder lab published its study of asymmetric biphasic truncated
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`exponential (BTE) waveforms (exponentially decaying currents and equal phase durations)
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`used in the transthoracic defibrillation of 100 kg calves. This study examined the efficacy of
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`several waveforms that were capable of being generated by a single capacitor bank.
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`Specifically, when a single capacitor BTE waveform is generated clinically, a single
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`capacitor bank is used, and the voltage and current delivered to a patient decay as the
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`capacitor discharges. At some point during this discharge, the shock is interrupted and the
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`polarity is reversed before reinitiating the shock. Then at some later point, the shock is
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`terminated.
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`(32) By 1985 it was known that biphasic waveforms were an improvement over
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`monophasic waveforms for both internal defibrillation and external defibrillation. It was
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`further known that the best known method of generating biphasic waveforms for both
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`internal and external defibrillation involved the use of a single capacitor biphasic truncated
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`exponential waveform. The Schuder lab’s 1984 BTE waveform study further established
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`that the individual pulse durations ranging from 2.8 to 7.54 ms (overall pulse durations of 5.6
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`to 15.08 ms) showed positive results. The study also showed that the ideal capacitance
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`values for human defibrillation were in the range of 64 to 196 microfarads. The general
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`recognition of the biphasic waveform as a more effective defibrillation waveform was again
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`illustrated in a 1988 paper from the Schuder lab entitled “General Superiority of Biphasic
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`Over Uniphasic Shocks in Cardiac Defibrillation.” This paper summarized all of the studies
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`to date of biphasic waveforms for defibrillation and concluded that biphasic waveforms were
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`more effective for defibrillation than monophasic waveforms.
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`(33) Following these advancements, further methods of modifying the biphasic
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`waveform have subsequently been employed in defibrillators. For example, internal and
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`external defibrillators containing an output circuit having four legs arranged in the form of
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`the letter “H” have been developed. “H-bridge” circuits were employed in defibrillators to
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`conduct a range of defibrillation pulse energies. Selectively switching on pairs of the
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`switches in an H-bridge circuit allows the pulse to generated by a single capacitance to
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`alternate between positive and negative polarities. Another way researchers modified
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`biphasic waveforms was by adjusting the truncation or “tilt” of the waveform. Tilt specifically
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`refers to the percentage difference between the ending voltage value and the initial voltage
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`value. Modifications to the tilt of the waveform allow for control of the amount of energy
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`delivered to the patient, thereby reducing the energy requirements of the defibrillator and
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`preventing myocardial damage from overexposure.
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`(34)
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`In sum, by August of 1993 it was well known that one could compensate for
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`differing patients’ impedances by (a) varying the predetermined duration of time over which
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`discharge occurred, (b) measuring voltage decay (or equivalent electrical parameter) and
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`stopping discharge when it reached a predetermined level, or (c) various combinations of
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`both. At the same time, by 1993 it would have been obvious to apply knowledge and
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`techniques learned from monophasic waveform research and implementations to biphasic
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`waveform implementations, and to apply knowledge and techniques learned from
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`implantable defibrillator research and implementations to external defibrillator
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`implementations.
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`VII.
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`THE ‘427 PATENT
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`(35) The ‘427 Patent is entitled “Electrotherapy Method,” and its disclosure relates
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`to an electrotherapy method and apparatus for delivering an electrical shock to a patient’s
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`irregularly beating heart to cause the heart to resume its natural beating rhythm. (‘427
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`Patent at 1:7-17). The electrical shock is applied as a biphasic truncated exponential
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`waveform. (Id. at 5:54-6:4, FIGs. 7 and 8). To deliver the waveform, an energy source,
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`such as a capacitor, is charged to a predetermined voltage, and subsequently discharged
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`through electrodes that are in electrical contact with the patient. (Id. 6:42-52). During the
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`first phase of the waveform, an electrical parameter, such as voltage or current, is
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`measured across the electrodes. (Id. at 5:20-33, 6:57-62). The first phase is truncated
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`when a predetermined period lapses, or when the measured electrical parameter reaches a
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`predetermined level, whichever occurs first. (Id. at 5:54-6:4, 7:63-67, FIGs. 6-8). The
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`second phase of the waveform can have a fixed duration, a duration based on an electrical
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`parameter measured during the second phase, or a duration based on a discharge
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`parameter, such as terminal voltage or duration, of the first phase. (Id. at 5:37-40, 6:20-22,
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`7:29-32).
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`(36) The ‘427 Patent claims priority to an application filed August 6, 1993. The
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`stated main difference between earlier electrotherapy apparatus and methods and the ‘427
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`Patent is the disclosure in the ‘427 Patent of an external defibrillator and defibrillation
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`method that automatically compensates for patient impedance differences by changing the
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`nature of the delivered electrotherapeutic pulse. (Id. at 2:35-39, 2:53-57). Automatically
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`compensating for patient impedance differences maximizes therapeutic efficacy across an
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`entire population of patients. (Id. at 2:26-30). Methods and apparatus for automatically
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`compensating for patient impedance differences were well-known by the time of the ‘427
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`Patent’s priority date.
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`(37)
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`I have reviewed Bell (Appendix B). Bell is one of many prior art examples
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`disclosing an external defibrillator that measures electrical parameters, e.g., voltage and
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`current, while delivering a shock to the patient and uses the measured electrical parameters
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`to determine when to stop delivering the shock. (Bell at 2:5-13, 3:3-13, FIGs. 1 and 2). Bell
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`further discloses that the output pulse width is limited to a maximum value for any given
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`setting. (Id. at 4:15-18). Bell explains that in the case of a high patient resistance, the
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`defibrillator would attempt to deliver the selected energy but would take too long and the
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`time out input will terminate the discharge before the measured voltage and current indicate
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`that the selected energy value is reached. (Id. at 4:30-40). Based on my knowledge and
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`experience in this field and my review of Bell, I believe that a person having ordinary skill in
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`the art would have recognized that Bell provides a method for applying electrotherapy to a
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`patient including discharging the energy source across the electrodes in the predetermined
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`polarity until the end of a predetermined time period or until an electrical unit measured
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`across the electrodes reaches a predetermined level, whichever occurs first.
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`(38)
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`In my opinion, it was also well-known that the voltage measured across the
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`electrodes decays due to the natural discharge pattern of the capacitors from which the
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`voltage originates. It was also well-known that the voltage on the capacitor bank, as it
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`decays, is mathematically related to the energy delivered to the patient. Therefore,
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`detecting that a measured voltage has decayed to a predetermined terminal voltage level is
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`the functional equivalent of monitoring the delivered energy and detecting when the
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`selected delivered energy value is reached. This voltage-energy relationship is described in
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`the Pless reference (Appendix C). In particular, Pless discloses that a desired tilt, which is
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`the ratio of the ending voltage value Vf to the starting voltage value Vi, can also be
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`expressed as a desired energy since J = 0.5*C(Vi 2 - Vf 2). (Pless at 1:34-47, 3:18-23).
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`Based on my knowledge and experience in this field and my review of Bell and Pless, I
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`believe that a person having ordinary skill in the art at the time would have recognized that
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`discharging the capacitors across the electrodes until the delivered energy reaches the
`
`selected energy value is the mathematical equivalent of discharging capacitors across the
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`electrodes until the voltage measured across the electrodes decays to a predetermined
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`terminal voltage level corresponding to the selected energy value.
`
`(39) Regarding the phrase “discharging . . . in the reversed polarity” as recited in
`
`claims 2-6 of the ‘427 Patent, a biphasic waveform had become known in the time between
`
`Bell and the filing of the ‘427 Patent as a preferred waveform for achieving defibrillation. I
`
`note that the ‘427 Patent recognizes that several prior art patents describe biphasic
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`waveforms. (‘427 Patent at 1:52-58). Pless also describes generating biphasic waveforms.
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`(Pless at 3:4-7). Pless’ biphasic waveform can have a negative pulse with a timed duration
`
`(Id. at 7:35-41), a negative pulse that is terminated when the capacitor voltage decays to
`
`less than a selected trailing voltage (Id. at 5:11-22), or a negative pulse with a duration that
`
`is a percentage of the duration of the positive pulse (Id. at 3:32-35). Based on my
`
`knowledge and experience in this field and my review of Bell and Pless, I believe that a
`
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`16
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`US Patent 5,593,427
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`person having ordinary skill in the art at the time would have been motivated to combine
`
`Pless’ biphasic waveform with Bell’s waveform control scheme because of the recognized
`
`increased effectiveness of biphasic waveforms over monophasic waveforms. Moreover, a
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`person of skill would have been motivated to make such a combination despite the fact that
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`Bell teaches an external defibrillator while Pless teaches an implantable defibrillator
`
`because the biphasic waveform was generally accepted as more effective than the
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`monophasic waveform regardless of whether the electrodes were external or implantable.
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`(40) Claims 9-18 of the ‘427 Patent include features relating to a multiphasic
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`waveform. As described in ¶ 39 above, such waveforms had become known in the time
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`between Bell and the filing of the ‘427 Patent as a preferred waveform for achieving
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`defibrillation, as recognized by the ‘427 Patent and described in Pless. Further, Kroll
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`(Appendix D) describes a biphasic waveform having a phase of optimum duration. (Kroll at
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`6:60-62). Kroll also describes producing a second pulse with a duration that is a fraction of
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`the duration of the first pulse (Id. at 7:1-3) and producing a second pulse that meets a fixed-
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`duration specification (Id. at 7:5-8). Based on my knowledge and experience in this field
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`and my review of Bell and Kroll, I believe that a person having ordinary skill in the art at the
`
`time would have been motivated to combine Kroll’s biphasic waveform with Bell’s waveform
`
`control scheme because of the increased effectiveness of biphasic waveforms over
`
`monophasic waveforms. Moreover, a person of skill would have been motivated to make
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`17
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`US Patent 5,593,427
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`such a combination despite the fact that Bell teaches an external defibrillator while Kroll
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`teaches an implantable defibrillator.
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`(41) Schuder (Appendix E), like Pless and Kroll, describes a multiphasic
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`waveform. Schuder describes bidirectional truncated exponential waveforms implemented
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`in clinical sized apparatus for transthoracic defibrillation (Schuder at 520, ¶3) and producing
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`a negative pulse with a timed duration (Id. at 520, ¶4; Table I). Based on my knowledge
`
`and experience in this field and my review of Bell and Schuder, I believe that a person
`
`having ordinary skill in the art at the time would have been motivated to combine Schuder’s
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`biphasic waveform with Bell’s waveform control scheme because of the recognized
`
`increased effectiveness of biphasic waveforms over monophasic waveforms.
`
`(42)
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`I have been asked to compare claim 1 of the ‘427 Patent with claim 4 of the
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`‘879 Patent. Claim 4 of the ‘879 Patent discloses a method for applying electrotherapy to a
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`patient, as does Claim 1 of the ‘427 Patent. The only substantive difference between Claim
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`4 of the ‘879 Patent and Claim 1 of the ‘427 Patent is that the ‘427 claim recites discharging
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`until the end of a time period or until the electrical unit decays to a terminal level (whichever
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`occurs first), while the ‘879 claim recites discharging until the end of a time period and until
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`the electrical unit decays to a terminal level. Based on my knowledge and experience in
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`this field, and in view of the prior art discussed above, I believe that a person having
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`ordinary skill in the art at the time would have considered the differences between the two
`
`claims to reflect nothing more than an obvious design choice because the difference
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`18
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`US Patent 5,593,427
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`between an “and” and an “or” is simply a selection from a very finite, two-member group
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`with no unpredictable results.
`
`(43)
`
`I have been asked to compare claim 9 of the ‘427 Patent with claim 9 of the
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`‘454 Patent. Claim 9 of the ‘454 patent discloses a method for applying electrotherapy to a
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`patient, as does Claim 9 of the ‘427 Patent. The ‘454 claim also discloses the “discharging”
`
`and “monitoring” features of the ‘427 claim. The ‘454 claim’s “shaping” feature is an
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`example of the ‘427 claim’s “adjusting” feature. The only substantive difference between
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`the claims is that the ‘427 claim recites discharging until the end of a time period or until the
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`electrical parameter reaches a predetermined level, whichever comes first, while the ‘454
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`claim recites both (a) controlling phase duration by a monitored electrical parameter and (b)
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`selecting a phase duration based on monitored elapsed time. In both the ‘454 claim and the
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`‘427 claim, both the electrical parameter and the elapsed time serve as limits on phase
`
`duration, and thus the discharge would occur until either factor was triggered, whichever
`
`occurs first.
`
`(44)
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`I declare that all statements made herein of my own knowledge are true and
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`that all statement made on information and belief are believed to be true; and further that
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`these statements were made with the knowledge that willful false statement and the like so
`
`made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the
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`United States Code.
`
`(45)
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`I declare under penalty of perjury that the foregoing is true and correct.
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`19
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`US Patent 5,593,427
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`/Wayne C. McDaniel/_______________
`Wayne C. McDaniel
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`/September 23, 2013/________________
`Date
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`20
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